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Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Radboud University Medical Center Nijmegen (Radboudumc)
Nijmegen, Netherlands
Erasmus Medical Center Rotterdam (Erasmus MC)
Rotterdam, Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Netherlands
Start Date
February 14, 2020
Primary Completion Date
October 31, 2026
Completion Date
December 31, 2028
Last Updated
May 16, 2024
236
ESTIMATED participants
Allopurinol
DRUG
Mannitol
DRUG
Lead Sponsor
dr. M.J.N.L. Benders
Collaborators
NCT06545734
NCT05268094
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03229538